Exhibit 10.1
THIS CONTRACT is made the 11th day of March 2003
[GRAPHIC OMITTED]
BETWEEN
1) ABP Diagnostics Ltd a company incorporated under the laws of England
and Wales having its registered office at Xxxxx Xxxxx, Xxxxxx Xxxxx,
Xxxxxxxxxxx Xxxxx, XX00 0XX (First Party) ("The Grantor")
And
2) EGYPTIAN ORGANIZATION FOR BIOLOGICAL PRODUCTS & VACCINES "VACSERA" -
an organization incorporated in Egypt, with its registered office in
Cairo - 51 Wezarat Al Zeraa St. Agouza - Giza, and represented in this
contract by its Chairman Xx. Xxxxxxx Xxx Salem El Abbadi (Hereafter
referred to as a part the Egyptian Ministry Of Health & Population,
(Second Party). ("The Licensee")
WHEREAS:
1) "The Grantor" is the owner of know how& advanced technology in
developing, manufacturing and selling medical diagnostic products
under the registered trade xxxx Focus Flo Through(TM), Focus Sure
Check(TM) as detailed in Schedule I of which The Grantor is the
proprietor and has available technical information of a secret and
confidential nature relating to the manufacture of a cassette and the
assembly of a range of individual diagnostic rapid test kits.
2) The Licensee owns current GMP Production facilities in Egypt. The
second party wishes to acquire the right to use such information and
to acquire the licence and rights mentioned below with respect to such
information regarding the transfer of know how & technology for the
Production of First Party products by Second Party.
WHEREAS:
Both parties wish to enter into this agreement in accordance with
international Regulations ( FEDEC ). As attached in schedule VIII,
Notwithstanding this both parties shall abide by the rules as laid
down by the state department of Egypt as attached in schedule IX
1
WHEREAS:
First Party agrees to grant the Second Party exclusive right to
formulate, label, package, register & sell the Products in the
Territory as defined in the attached list according to the time frame
of this contract.
WHEREAS:
The following principles of the commercial working terms will be
executed accordingly:
1- The First Party confirmed that the Products which will be sold
and or licensed to the Second Party, is freely sold in Country of
Origin and available in other countries outside Country of
Origin.
2- The Second Party agreed to purchase during phase one bulk
unlabelled from the First Party as specified hereunder: -
(sensitive information) , C.I.F Cairo
1. Definitions
In this contract the following expressions shall have the following
meanings:
`Licensed products' The technology in the field of
diagnostics can be defined in general
terms as developing methods to detect
the presence or absence of specific
infectious agents or biochemical
disorders in the human body, for example
the Hepatitis virus, in accordance with
the technical information and sold by
The Grantor under its registered trade
xxxx Focus
`Licensed Territory' Egypt
`Equipment' All equipment exclusively required for
the manufacture of the Licensed Products
including the testing of the Licensed
Products
`Technical Information' Technical knowledge and data
specifications of materials and the
manufacturing techniques and other
information of a secret and confidential
nature in existence at the date of this
2
Contract which are necessary to enable
The Licensee to manufacture the Licensed
Products properly and efficiently in
reasonable quantities of a standard and
quality similar to the standard and
quality of similar products manufactured
by The Grantor and to be of value in
selling the Licensed Products as
detailed in The Grantors Manual supplied
as part of the technology transfer
programme 2. Supply of Technical
Information
2.1 The Grantor agrees to supply the necessary know how and training for
Vacsera to produce the following tests in a flow through format
subject to a future letter of intent from Vacsera:
o HIV 1 & 2
o HCV
o H. Pylori
o TB
Conditional upon the purchase of raw materials as listed in Schedule V
by Vacsera Ltd.
2.2 The Grantor agrees to supply the necessary know-how and the necessary
training for Vacsera to produce the following test in a lateral flow
format:
o HBsAg
Conditional upon the purchase of raw materials as listed in Schedule V
by Vacsera Ltd.
2.3 The basic equipment as listed in Schedule II will be purchased by The
Licensee. This equipment can be supplied by The Grantor or any other
supplier according to the Grantor specifications.
2.4 The basic chemicals as listed in Schedule III, being sufficient to
produce an initial 250,000 tests, are supplied at The Licensee's cost.
Future purchases of these materials will be at The Licensee's cost.
The Grantor will continue to supply to The Licensee these basic
chemicals at The Licensee's cost, as they are required, taking into
consideration the International market prices.
3
2.5 Schedule VII attached to the contract identifies the components being
supplied per test
2.6 Quality control is the responsibility of The Grantor who will train
The Licensee's personnel and will continually audit The Licensee's
facility to ensure that this facility produces products that meet the
highest possible quality standards at all times
2.7 Subject to the requirements under Clause 11 and the achievement of
performance criteria under Schedule IV, The Grantor hereby grants to
The Licensee an exclusive licence to use the Technical Information for
the manufacture and sale of the Licensed products in the Licensed
Territory for the duration of this Contract
3. Duration
Subject to clause 10, this Contract shall continue in force for a
period of 10 years from the date written above unless determined by
either party giving to the other not less than 6 months written notice
to that effect expiring at any time. This Contract may be extended by
mutual contract between the parties on like terms.
4. Marking
4.1 In respect of any Licensed Products manufactured by The Licensee which
are in the opinion of The Grantor's management of the same standard as
to qualify as The Grantor's own products of the same type and shall
meet The Grantor's quality control standards The Licensee shall be
licensed by The Grantor to use the trade xxxx Focus Rapid Test Kits if
The Licensee requires,
4.2 Licensed Products manufactured by The Licensee under this Contract
shall be marked `made under license from ABP Diagnostics Ltd.' such
marking to be in a form approved by The Grantor.
5. Grantor's Expenses
The Licensee will cover The Grantor's costs in connection with travel
to and from Egypt from UK, accommodation, and subsistence costs in
Cairo for up to three people from the commencement of the transfer
programme for the duration of the first month. Thereafter this
provision will be by mutual agreement.
4
6. Warranties
The Grantor hereby covenants to The Licensee that it has in its
possession the necessary formulae and other information required to
produce the reagents referred to in this contract and assures The
Licensee of the continuous supply of such reagents of the same nature
and quality regardless of any changes in key personnel associated with
The Grantor.
7. Fee
7.1 The Licensee shall make a Royalty Payment of (Competition sensitive)
have been produced but not later than two years after the contract has
been signed, payable quarterly in arrears in US$ by Bank Transfer to
the bank account below for a period of three years after the first
payment:
HSBC Bank plc
Account Name: ABP Diagnostics Ltd
7.2 The Licensee shall purchase reagents at the prices listed in Schedule
V. These prices shall remain in force for 12 months from the date of
signing of the first letter of credit. A tender will be issued by The
Licensee to verify & confirm the competitive prices. Thereafter prices
will be reviewed annually and will be governed by local price index
8. Currency or payment and exchange rates
The Licensee shall make the payments provided for in clause 7 to
9. Secrecy
Both parties, "The Licensee" & "The Grantor" shall hold all Technical
information as absolutely Confidential.
Confidential information shall mean, all the technical & commercial
information in all forms provided by both parties in relation to this
contract
9.1 The parties agree to exercise all reasonable precautions to maintain in
strict confidence all Confidential Information received from the other, and
will only use this Confidential Information for the purposes of defining in
this Agreement.
9.2 Neither Party shall use the Confidential Information for any other
purpose rather than purposes specified in this agreement.
5
9.3 upon expiration of this Agreement or at any earlier date if the
disclosing Party so request, both parties shall return or destroy all
written portions of Confidential Information received hereunder from the
other Party as well as all copies made thereof.
9.4 As far as legally permitted, the parties hereto shall cause, instruct,
direct and oblige any officers, employees or other persons who have
rightfully access to any of the Confidential Information to keep the same
confidential.
9.5 Any obligations of secrecy incurred by either Party with respect to
Confidential Information transmitted under this Agreement shall cease
immediately in case any of the following circumstances shall arise:
9.51 The portion of the Confidential Information involved enters the public
domain through no fault of the Party to whom the information was disclosed,
or
9.52 The disclosure is authorized in writing by the Party from whom the
information was received, or
9.53 The portion of the Confidential Information involved is received from
a third Party without restriction on disclosure by the Party to whom
information was disclosed, or
9.54 A term of ten (10) years from the effective date of this Agreement has
elapsed.
10. Termination
If The Licensee shall commit or allow to be committed a breach of any of
the covenants contained in this contract and on its part to be performed or
observed and shall not remedy (if capable of being remedied) such breach
within 14 days after notice is given to it by The Grantor requiring such
remedy, or if The Licensee shall go into liquidation (whether compulsory or
voluntary not being a voluntary liquidation for the purpose of amalgamation
or reconstruction) or shall have a receiver appointed of its assets and
undertaking or any part of them or any distress execution or other process
shall be issued against any property of The Licensee, The Grantor shall be
at liberty in every and any such case by notice in writing to determine
this Contract and thereupon all licences granted pursuant to this contract
and all rights of The Licensee under it shall forthwith cease and determine
but without prejudice to any right or remedy of The Grantor to xxx for and
recover any sums then due and to the remedy of either party in respect of
any previous breach of any covenant contained in this Contract.
11. Effect of Contract being invalidated as respects any region
Any provision or provisions of this Contract which in any way contravene
the Law of any state or region (such as by way of example the law of the
European community) in which this Contract is effective shall in such state
6
or region to the extent of such contravention of law be deemed severable
and shall not invalidate any other provision or provisions of this contract
12. Non-assignability
Neither Party shall have the right to assign or transfer its rights or
obligations under this Agreement, either in whole or in part, without the
prior written consent of the other Party. Should any such right or
obligation be so assigned by either Party with written approval of the
other Party, the assigning Party shall remain responsible as guarantor for
the correct performance by its assignee(s).
13. Law applicable
This Agreement shall be governed by and construed in accordance with the
substantive laws of Egypt.
14. Arbitration
14.1 any dispute between the Parties that cannot be settled by mutual
agreement, concerning the interpretation, the performance of the
obligations, breaches, termination or enforcement of this Agreement or
which arises out in connection with this Agreement shall be settled
exclusively by arbitration under the International Arbitration Rules of the
Paris Court of International Arbitration (PCIA).
14.2 the place of arbitration shall be Cairo (Egypt).The Arbitrating
Tribunal shall consist of one arbitrator to be appointed by the Parties by
mutual agreement or, failing such agreement, by the Chairman of UNCITRAL,
office in Cairo upon the request of the most diligent Party.
14.3 all proceedings of the arbitration, including arguments and briefs,
shall be conducted in the English language. Any award of the Arbitrating
Tribunal shall be in writing, in the English language and shall state the
reasons upon which it was based. The written decision of the Arbitrating
Tribunal shall be served to both parties.
14.4 tribunal shall be final and binding on the Parties. The cost of the
arbitration shall be borne by either or both Parties as the Arbitrating
Tribunal may decide. Judgement upon any award rendered by the Arbitrating
Tribunal may be entered for execution in any Court of competent
7
jurisdiction in any Country, or application may be made to such Court of a
judicial acceptance of the award and an order of enforcement, as the law of
such jurisdiction may require or allow.
15. FORCE MAJEURE
15.1 A Party hereto shall not be liable or responsible for damages or in
any manner whatsoever to the other Party for failure or delay in performing
and fulfilling any provision of this Agreement when such failure or delay
is due to acts of public authorities, war, civil commotion, embargoes,
impossibility to get raw materials, energy and other supplies, strikes of
whichever kind and more generally to a reason that is beyond the reasonable
control of the affected Party.
15.2 In the event as a direct consequence of any such events a Party is
prevented to perform and fulfil any of its obligations hereunder, the
affected Party shall notify in writing the other Party of its inability to
perform and the reasons of such inability within 21 days since the
incidence with a certificate issued by concerned authority attesting such
event or events.
15.3 During the continuance of the force majeure event the performance of
the Agreement shall be suspended. Thereafter, the affected Party shall
inform the other Party of the termination of the force majeure event.
15.4 should the force majeure event continue for a period longer than 3
(three)months, the other Party may, in its own discretion, terminate this
Agreement.
16. Miscellaneous
16.1 should any clause or sub-clause or part of a clause in this Agreement
be held to be invalid because it contravenes any applicable legal
provision, the Parties agree to modify the Agreement to the extent
necessary to ensure compliance with such legal provision. Notwithstanding
the invalidity of any such clause or sub-clause or part of a clause, all
other terms of this Agreement shall remain in full force and effect.
16.2 No amendments or additions to any of the terms of this Agreement shall
be valid unless agreed upon in writing and signed on behalf of both
Parties.
16.3 Failure of either Party to enforce any of the provisions of this
Agreement or any right with respect thereto or failure to exercise any
election provided for herein shall in no way be considered a waiver of such
provision, right or election, or in any way affect the validity of this
Agreement. The failure of either of the Parties to enforce any of said
provisions, rights or elections shall not preclude or prejudice such Party
from later enforcing or exercising the same or other provisions, rights or
elections which they may have under this Agreement.
8
16.4 All rights and remedies of the Parties or of either of them hereunder
shall be in addition to all other legal rights and remedies belonging to
them and the same shall be deemed to be cumulative and not alternative to
such legal rights and remedies. The termination of this Agreement shall not
affect any right or claim which shall or may have accrued or arisen prior
thereto.
16.5 This Agreement supersedes all prior agreements, representations,
statements or warranties, whether oral or written, made by or on behalf of
any Party hereto and constitutes the entire agreement between the Parties
relating to the provisions stated herein.
16.6 Notices under this Agreement shall be served on each Party at his
respective registered offices for the time being. Notice may be given by
letter or by fax and confirmed by letter; and each letter containing or
confirming notice will be sent by air mail addressed to the other Party at
the address for service and will be deemed to have been received on the
fifth day (not including Saturdays, Sundays or public holidays) after
dispatch of the notice.
16.7 The following Schedules form an integral part of this Agreement:
Schedules I - Products
Schedules II - Minimum Equipment requirements
Schedules III - List of chemicals required
Schedules VI - Production forecast
Schedules V - Price List
Schedules VI - Royalties
Schedules VII - Detailed components list
Schedules VIII - FEDEC International regulations
Schedules IX Egyptian state department rules
16.8 The Parties agree that:
a) the collection or processing of personal data supplied under this
Agreement is exclusively for the purpose of enabling the Parties to perform
their activities in adequate manner, and that the personal data is and will
be processed lawfully and fairly in order to guarantee its safety and
privacy, by means of both automated systems and hard copies using manual,
computerised and/or telecommunication systems;
b) For the stipulation of the contractual relation, the collection of
personal data is obligatory in order to satisfy legal requirements,
including fiscal law;
c) The personal data and its relevant processing will not be object of
communication or diffusion in any cases not authorised by law and will be
performed according to methods authorised by the law; in particular, it can
be communicated/diffused by subsidiary, parent and affiliates, to external
subjects who perform specific jobs for the Parties, to Companies,
Authorities, Syndicates or Associations, to Banks for the management of
collections and payments, to subjects responsible for the revision of the
financial statements of the Parties and to the Public Authorities or
Administrations for the fulfilment of the law.
9
16.9 This Agreement is executed in two counterparts, each of which shall be
deemed to be an original.
EXECUTED by the parties
Signed by:
---------------------------------------------
Dr AEJ Xxxxxxxx
for and on behalf ABP Diagnostics Limited
in the presence of:
Signed by
--------------------------------------------------
Dr MM Abaddi
for and on behalf of Vacsera
in the presence of:
10
Schedule I
(Completion sensitive)
Antigen Price
See Schedule V
Volumes
See Schedule IV
Royalties
See Schedule VI
1. Hepatitis B (HBsAg)
------------------
2.
Volumes
-------
See Schedule IV
Antigen Price
-------------
See Schedule V
Royalties
---------
See Schedule VI
11
Schedule II
The minimum equipment required is:
---------------------------------
(Competition sensitive)
12
Schedule III
List of Chemicals required to set up the manufacturing facility
(Competition sensitive)
Schedule IV
(Competition sensitive)
13
Schedule V
ABP Diagnostics Component Price List
(Competition sensitive)
Schedule VI
Royalties
(Competition sensitive)
Schedule VII
Detailed Components List
(Competition sensitive)
14